The Arrival of CRISPR: Why The Genetically Modified Human Is No Longer Science Fiction

The 1997 film Gattaca, set in “the not too distant future,” envisioned a world where parents possess complete control over the DNA they pass on to their children. The “future” forecasted in the film is now closer than ever with the latest advancement in genetic engineering known as CRISPR-Cas9 (“CRISPR”).

With the use of CRISPR, scientists, for the first time ever, can precisely edit, delete, and rearrange the DNA of nearly any living organism, including humans. Genetic editing using CRISPR takes place inside an embryo on what is known as the germ line. This allows scientists to edit the genetic material that can be inherited by the next generation. After altering, a genetic trait can be passed on to future generations. The potential of editing the germ line does not just mean that we will be able to control a child’s eye or hair color, it could also mean the ability to eliminate hereditary diseases altogether.

Although scientists have not begun using CRISPR to edit viable human embryos (Chinese researchers have used it with nonviable embryos), they have experimented with it to alter the DNA of mosquitos known for transmitting the Malaria, West Nile, and Zika viruses. In doing so, they have been able to ensure that these mosquitoes only produce sterile offspring. If successfully applied to wild mosquito populations, the lives of thousands of people that contract these deadly viruses each year would undoubtedly be saved. However, the consequences that could be created in ecosystems with which these mosquito populations interact remain unclear.

While CRISPR stands at the brink of irreversibly changing how we interact with organisms on this planet, there is frighteningly little formal regulation in the United States governing its use. At the Federal level, the regulation of genetic experiments on embryos currently falls within the jurisdiction of the Federal Drug Administration (“FDA”) and the National Institute of Health (“NIH”). Although the NIH has explicitly refused to provide public funding to projects relating to the genetic editing of human embryos, the current restrictions imposed by the FDA are minimal— limited only to concerns regarding safety and efficacy. In this limited capacity, the FDA’s authority extends to CRISPR’s application to human embryos, but not necessarily to the technology itself.

While the FDA possesses the authority to limit the use of CRISPR to create a genetically modified child, the FDA’s jurisdiction ends at the U.S. border. A lack of central authority is problematic given the fact that the human gene pool is one aspect of humanity that is truly shared by everyone on this planet. Furthermore, such concerns are not alleviated when the regulatory schemes of other countries are examined. For instance, two other leading countries in genetic editing research, the U.K. and China, have no concrete legal restrictions governing edits to the human germ line and none appear to be forthcoming.

Yet, the scientific community may be prepared to self-regulate the research and implementation of new DNA technology. Experts in the field have already spoken out about the need for a global consensus before any attempt to genetically modify a human embryo is made. Furthermore, Phillip Campbell, the executive of Nature, an influential science journal, has said that the journal has already rejected several papers on the subject, either because they did not meet ethical standards or were poorly done.

In an area with such little formal regulation, it is not surprising that CRISPR has ignited a serious policy debate as to how DNA editing should be regulated. On the one hand, proponents of the technology point to the clear benefits of being able to pre-emptively strike at debilitating conditions that millions of individuals are genetically predisposed to. On the other hand, there are glaring ethical concerns anytime technology is used to alter human reproductive processes. Perhaps even more concerning, are the potential unintended ecological consequences associated with CRISPR’s ability to alter the genetic makeup of entire species of plants and animals. And consider also statements from James Clapper, the U.S. Director of National Intelligence, who has gone so far as to add gene editing technologies such as CRISPR to the list of threats posed by “weapons of mass destruction and proliferation.”

With the apparent potential to do as much harm as it can good, CRISPR is the ultimate double-edged sword. That being said, how the current framework will sufficiently account for the virtually limitless applications of CRISPR remains difficult to see. What will an effective regulatory framework look like? Will ethical concerns about playing God force this technology to largely remain a figment of our science fiction novels? Or will human curiosity win the day and prevent it from being hamstrung by government regulation? Only time will tell what “the not too distant future” holds for CRISPR.